Evidence map›Paper›PMID 31366659›Full record

ArticleBMJ open2019

Effectiveness of a mobile preconception lifestyle programme in couples undergoing in vitro fertilisation (IVF): the protocol for the PreLiFe randomised controlled trial (PreLiFe-RCT).

Tessy Boedt, Eline Dancet, Sharon Lie Fong, Karen Peeraer, Diane De Neubourg, Sofie Pelckmans, Arne van de Vijver, Jan Seghers, Katleen Van der Gucht, Ben Van Calster and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03790449 (Evaluation of a Mobile Preconception Lifestyle Programme in Couples Undergoing in Vitro Fertilisation), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
4.4field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03790449 naterminatednot on this map

Evaluation of a Mobile Preconception Lifestyle Programme in Couples Undergoing in Vitro Fertilisation: a Multicentre Randomized Controlled Trial (PreLiFe-RCT)

TypeinterventionalSponsorUniversitaire Ziekenhuizen KU LeuvenRan2019 to 2021Enrolled211ConditionsInfertilityArmsPreLiFe-programme, Attention Control Programme
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Preconception lifestyle advice for people with infertility.The Cochrane database of systematic reviews · 2021
    Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Observational
  8. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 2 countries.

Tessy BoedtDepartment of Chronic Diseases Metabolism and Ageing, KU Leuven, Leuven, Belgium.ORCID 0000-0001-5417-4258
Eline DancetLeuven University Fertility Centre, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0003-0356-930X
Sharon Lie FongLeuven University Fertility Centre, University Hospitals Leuven, Leuven, Belgium.
Karen PeeraerLeuven University Fertility Centre, University Hospitals Leuven, Leuven, Belgium.
Diane De NeubourgAntwerp University Hospital, Centre for Reproductive Medicine, Edegem, Belgium.
Sofie PelckmansDepartment of Obstetrics and Gynaecology, Imelda Hospital Bonheiden, Bonheiden, Belgium.
Arne van de VijverDepartment of Obstetrics and Gynaecology, General Hospital Sint Jan Bruges-Ostend, Brugge, Belgium.
Jan SeghersDepartment of Movement Sciences, KU Leuven, Leuven, Belgium.
Katleen Van der GuchtLeuven Mindfulness Centre, KU Leuven, Leuven, Belgium.
Ben Van CalsterDepartment of Development and Regeneration, KU Leuven, Leuven, Belgium.
Carl SpiessensLeuven University Fertility Centre, University Hospitals Leuven, Leuven, Belgium.
Christophe MatthysDepartment of Chronic Diseases Metabolism and Ageing, KU Leuven, Leuven, Belgium.
Leuven Institute for Fertility and Embryology · BEKU Leuven · BEAntwerp University Hospital · BEAZ Sint-Jan · BEImelda Hospital · BELeiden University Medical Center · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionInfertility and in vitro fertilisation (IVF; with or without intracytoplasmic sperm injection) result in considerable emotional and financial burden. Increasing evidence suggests that lifestyle factors, including diet, physical activity and personal well-being, are associated with IVF-success rates. Currently, IVF is not routinely combined with a lifestyle programme. The preconception lifestyle (PreLiFe) randomised controlled trial (RCT) assesses the effects of a new mobile PreLiFe programme in couples undergoing IVF. METHODS AND ANALYSIS: A multicentre RCT including 460 heterosexual couples starting IVF in Belgian fertility clinics. IVF couples are randomised between an attention control group or the PreLiFe programme for a period of 12 months or until an ongoing pregnancy is confirmed by ultrasound. The attention control programme includes a mobile application with treatment information (ie, appointments and medication instructions) in addition to standard care. The PreLiFe programme includes a mobile application with the same treatment information in combination with a lifestyle programme. This new lifestyle programme includes tailored advice and skills training on diet, physical activity and mindfulness in combination with text messages and telephone interaction with a healthcare professional trained in motivational interviewing. The primary outcome of this RCT is the cumulative ongoing pregnancy rate within 12 months after randomisation. Secondary outcomes include changes in diet, physical activity, emotional distress, body mass index, waist circumference, quality of life and other reproductive outcomes including IVF discontinuation, clinical pregnancy rate and time to pregnancy. Additionally, partner support and the feasibility (use and acceptability) of the PreLiFe programme will be evaluated in the intervention group. Analysis will be according to intention to treat. ETHICS AND DISSEMINATION: This study has been approved by the Medical Ethical Committee of the Leuven University Hospital (Belgium) and the other recruiting clinics. The findings of this RCT will be disseminated through presentations at international scientific meetings and peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT03790449; Pre-results.

Indexed as

Fertilization in VitroLife StyleMobile ApplicationsPregnancy RateQuality of LifeBelgiumFemaleHumansLogistic ModelsMaleMulticenter Studies as TopicPregnancyRandomized Controlled Trials as Topicdietfertility treatmentinfertilityIVFlifestylemHealthmindfulnessphysical activityreproductive outcome

Identifiers

PMID31366659
PMCPMC6678004
OpenAlexW2965450027

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.